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PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives
This study has been completed.
Sponsor:
Federico II University
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00948402
First received: July 24, 2009
Last updated: October 13, 2009
Last verified: October 2009
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Purpose
Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index. Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003 and p<0.001, respectively). After treatment, independently of body weight, only in MET group PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p<0.001), and QUICKI and ISI increased (p<0.001). Insulin sensitivity indexes improvement correlated significantly with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein over-expression in obese PCOS women with IR reduced after a six month treatment with MET, while remained unchanged in the OCP group. The reduction was independent of body weight, and correlated with insulin sensitivity indexes. This effect further supported MET as a more effective therapy than OCPs for obese PCOS women with IR, also when fertility is not required.
| Condition | Intervention | Phase |
|---|---|---|
| Polycystic Ovarian Syndrome Insulin Sensitivity | Drug: Metformin Drug: oral contraceptive | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome |
Resource links provided by NLM:
Further study details as provided by Federico II University:
Primary Outcome Measures:
- PED/PEA-15 protein expression [ Time Frame: 6 months ]
Secondary Outcome Measures:
- BMI, plasma glucose, plasma insulin, insulin sensitivity indexes (1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI, whole-body insulin sensitivity index). [ Time Frame: 6 months ]
| Enrollment: | 20 |
| Study Start Date: | December 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: metformin |
Drug: Metformin
metformin 1250 mg three times daily
Other Name: Biguanides
|
| Active Comparator: oral contraceptive |
Drug: oral contraceptive
30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month.
Other Name: estroprogestins
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years to 28 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- female
- premenopausal
- obesity
- PCOS.
Exclusion Criteria:
- pregnancy
- type 2 diabetes or impaired glucose tolerance
- hypothyroidism
- hyperprolactinaemia
- Cushing's syndrome
- nonclassical congenital adrenal hyperplasia
- previous (within the last 6 months) use of oral contraceptives
- glucocorticoids
- antiandrogens
- ovulation induction agents
- antidiabetic and antiobesity drugs, or other hormonal drugs.
None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00948402
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948402
Sponsors and Collaborators
Federico II University
Investigators
| Principal Investigator: | Annamaria Colao, MD PhD | Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Annamaria Colao, Dept of Moll Clin Endocrinol Oncol, University Federico II of Naples |
| ClinicalTrials.gov Identifier: | NCT00948402 History of Changes |
| Other Study ID Numbers: |
NeuroendoUnit-11 |
| Study First Received: | July 24, 2009 |
| Last Updated: | October 13, 2009 |
Keywords provided by Federico II University:
|
PED/PEA-15 protein PCOS IR |
metformin OCP Oral Contraceptive |
Additional relevant MeSH terms:
|
Syndrome Hypersensitivity Insulin Resistance Polycystic Ovary Syndrome Disease Pathologic Processes Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ovarian Cysts Cysts Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Metformin Contraceptive Agents Contraceptives, Oral Hypoglycemic Agents Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on August 18, 2017